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University of California, Davis

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment Joseph M. Tuscano, M.D.
Associate Professor of Medicine
Department of Internal Medicine
Division of Hematology and Oncology
University of California, Davis
Contacts Joseph M. Tuscano, M.D.
Format PowerPoint?
* Download
Materials Provided PowerPoint? Presentation (29 slides)
Title Translation of Anti-CD22 Monoclonal Antibodies for the Treatment of Lymphoma: The Good, The Bad, and the Ugly
Topics Description This presentation is about one researchers first hand experience in developing a promising therapeutic treatment for lymphoma and the hurdles of moving the research from bench to bedside. There are some good guys, some bad guys, and some plain undesirables in this particular saga. Each in their own capacity either helped or hindered bringing forth a new promising treatment that could affect many people suffering with lymphoma cancers.

The purpose this presentation is it identify the promising functions that are in place that assist the researcher in an academic setting to engage with industry and get treatments to those in need and is fairly compensated (via patents, licensing agreements and royalties).

NIH - Rapid Access to Intervention Development (RAID) is intended to reduce common barriers experienced between lab discoveries and clinical trials of new therapeutic entities. RAID assists in facilitating alliances with industry so a more efficient translation of a promising discovery can take place. NIH-RAID acts as a consulting body and provides services based on the type of research and the stage of the research.

The Bayh-Dole Act is a Patent and Trademark Laws Amendment (1980) that has created a uniform patent policy among many federal agencies that fund research. Universities are able to have ownership of inventions made under federally funded research. The royalties are shared by the inventor, with a portion going to the university, and some to support the technology transfer process. The Bayh-Dole Act gave universities control of their inventions.

Technology Transfer Office is then responsible to act in the interest of the university to patent the discovery, engage in marketing, and developing collaborations between a university and industry in an expeditious manner.

There are many factors that can influence the inventor and either support or impede the development of promising new therapeutics. Profitability, patentability, licensing and the need/requirement for multiple licensing partners, production issues, the need/requirement for academic advancement, the targeted disease and if the therapeutic is an unmet need all can influence and play a role in the success of translating a therapeutic from the bench to the bedside.

Dr. Tuscano’s presentation demonstrates we still have too many issues with policies, and industrial partners (to name two) that are impeding the process at a high cost of getting promising new treatments out to the society.
Keywords Bayh-Dole Act; Bench-to-Bedside; Commercial Application; Data; Design; Ethics; Grant Support; Industrial Partners; Institutional Policy; Inventions; Licensing; Patents; Plant; Public Use and Benefit; Rapid Access to Intervention Development (RAID); Technology Transfer Office; Therapeutic; Treating Lymphoma; Utility
See Also

Topic Data Acquisition Management Sharing and Ownership, Human Subjects, Animal Welfare, Collaborative Science, Other
Topic revision: r4 - 17 Nov 2011 - 12:32:18 - MaryBanach
ResearchEthics.Translation_Of_Anti_CD22_Monoclonal_Antibodies_For_The_Treatment_Of_Lymphoma_The_Good_The_Bad_And_The_Ugly moved from ResearchEthics.TranslationOfAntiCD22MonoclonalAntibodiesForTheTreatmentOfLymphomaTheGoodTheBadAndTheUgly on 06 Jul 2009 - 19:00 by CTSpediaAdmin
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